29.-30.11.17

Vienna: Stability Testing for Drug Substances and Drug Products

Dr. Hiltrud Horn will provide you with essential hints on how to write the stability section of the CTD for drug substances and drug products. Furthermore, she will talk about post-marketing stability studies. You will get practical advice about the impact of changes on stability and how to cope with these in the regulatory world. This course is of specific interest for CMC-people who want to be up to date and like to know how to avoid stability issues in their projects.

For more information please visit the following website:
https://www.gmp-navigator.com/daten/seminarpdf/ECA-Stability-Testing-2017.pdf

(Conference organized by Concept Heidelberg)



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  • 10.03.2017
    News for the Industry
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  • 26.07.2013
    News on Change Control/Variations:
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  • 31.01.2013
    EU: Revised GMP-Annex 2 published - Details defined for biological products including ATMPs
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EU: New Variation System in force as of Jan 1, 2010. Filing of variations will be faster, easier, and more flexible. Have you considered that your Change Control System needs to be updated accordingly?
EU: Centralised Marketing Authorisation Procedure for ATMPs needed Have you already filed your application? The time clock is ticking. Transitional periods will be over soon.
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